By L.A. Williams, Correspondent
Christian Action League
June 20, 2014
North Carolina children suffering from severe seizure disorders could be one step closer to a new treatment. The House gave its approval Thursday to the use of cannabidiol (CBD) oil, an extract made from genetically modified marijuana plants.
“This plant is high in CBD (10 percent) and low in THC (tetrahydrocannabinol) with less than .3 percent,” explained Rep. Pat McElraft (R-Carteret), one of the bill’s four primary sponsors, as she addressed the Health and Human Services Committee on Wednesday. On Thursday she told the House not to be afraid that the measure was “the camel’s nose under the tent” regarding medical marijuana.
“The M-word is not even in the bill,” she said, describing the tightly written proposal as one that has been “a long time coming for some special and precious children.”
Labeled “Hope 4 Haley and Friends” in honor of 6-year-old Haley Ward of Newport, House Bill 1220 would create a CBD oil compassionate use registry for those who have intractable seizure disorders and would protect patients and caregivers from drug charges related to the product. Further, it would offer immunity to neurologists who oversee the use of the extract for their patients, who would be required to meet a number of strict criteria. For example, the patient must be under the care of a neurologist affiliated with the University of North Carolina at Chapel Hill, Duke University or Wake Forest University, and must have been diagnosed with intractable epilepsy (a seizure disorder that does not respond to three or more treatment options overseen by the neurologist). Parents or guardians who are to administer the medicine must first acquire a $50 hemp extract registration card from the Department of Health and Human Services, which will make its database available to local law enforcement and health officials.
“Because this is drafted in such a tight way, it is so different than what we look at when we talk about medical marijuana bills,” Rep. Marilyn Avila (R-Wake) told fellow lawmakers, as she outlined four major differences.
“It is limited to a specifically well recognized, diagnosed medical condition,” Avila said, whereas medical marijuana is typically made available for anyone claiming to have chronic pain.
Secondly, she pointed to controlled production, the fact that CBD oil is manufactured in a pharmaceutical grade laboratory and results in a liquid with a dosage that can be controlled for weight or other factors as opposed to marijuana that can vary widely in strength from plant to plant.
Delivery method is another difference listed by Avila, who explained that the hemp extract is swallowed allowing direct entrance into the body, whereas marijuana is smoked, meaning “you can’t measure how much you get or how long it stays in your body.”
“Most important of all, I think, for me as a scientist, the whole process is under the supervision of licensed medical specialists who have spent a lot of time studying the disease. They understand the medicines involved and they can watch for symptoms in their patients to see what is happening,” she concluded.
Avila was among a number of lawmakers who adamantly oppose medical marijuana but rose to support Hope 4 Haley and Friends during a House session marked by emotion as members described the desperation of children and families affected by constant seizures.
Rep. McElraft related the case of Zora Carlin, who has Dravet Syndrome and suffers an average of 40 seizures per day even as doctors have tried 14 different medications to stop them. Carlin’s father, Steve, addressed the Health and Human Services Committee Wednesday on behalf of his own child and thousands of others, some of whose families are now separated as the patient and one parent seek treatment in states such as Colorado, where CBD oil is legal and produced via a strain of the plant called Charlotte’s Web.
Members of the House also heard about LGS, Lennox-Gestaut Syndrome, the type of epilepsy that plagues Haley Ward, who is severely developmentally delayed because of the illness.
“Children that have these syndromes have a genetic disorder that makes them much more prone to have electrical instability in their brains,” explained Rep. Jim Fulghum (R-Wake), a neurosurgeon and primary bill sponsor. “They don’t get to develop motor skills, to talk, to walk, that kind of thing. They have an inability to grow because they are having so many seizures they never get back to baseline. And every one they have makes the next one worse.”
He said CBD oil has been shown to have “fairly dramatic results” in its early trials and that the FDA has seen fit to fast-track the drug. A British company, GW Pharmaceuticals, which produces a cannabidiol drug called Epidiolex, is also in the process of offering clinical trials of its medication, studies of which may run parallel to those encouraged by the bill at Tar Heel universities.
Even with the fast-track process, lawmakers said it would be at least two years before the drug could win full FDA approval and become available by prescription, thus pointing to the need for bills like Hope 4 Haley and Friends.
Having passed the House, 111 to 2, H 1220 will now go to the Senate.